Launches / Withdrawals

Medtronic has gained CE Mark approval for its Evera MRI™ SureScan® implantable cardioverter-defibrillator (ICD) System. The company says this is the first and only ICD system approved for magnetic resonance imaging (MRI) scans positioned on any region of the body.

Boston Scientific Corporation has received U.S. FDA clearance and CE Mark approval in Europe for the Expect™ Slimline (SL) Needle, which means it is now globally available for Endoscopic Ultrasound-Fine Needle Aspiration (EUS-FNA) procedures.

DePuy Synthes Power Tools has launched its “Next Generation”, 30% more powerful electric drill system for neurosurgery, otology and spinal procedures.

This weekend sees the American Association of Neurological Surgeons (AANS) annual meeting, starting April 7, 2014. Mazor Robotics is using the occasion to debut and officially launch the new Renaissance Guidance System brain module, which it says is FDA-cleared for both spine and brain surgery.

Robot surgery device specialist Intuitive Surgical, Inc., has announced the U.S. FDA clearance and introduction of the da Vinci Xi Surgical System, which it says represents a technological leap forward in replacing large-incision abdominal surgeries (open surgery) with a minimally invasive approach.

Zimmer Spine, Inc., has announced the U.S. market launch of a comprehensive family of Puros Demineralized Bone Matrix (DBM) with Reverse Phase Medium (RPM) Putty, Putty with Chips, Gel and Paste, and Puros DBM Block and Strip products

AccessClosure Inc., has commercially launched its Mynx Ace Vascular Closure Device at ACC 2014. The company says the device is a safe and secure vascular closure product that provides consistent results with a new, easy-to-use deployment system to seal femoral artery access sites.

Following FDA clearance in January, ACIST Medical Systems, Inc., has now announced the global introduction of the new ACIST|RXi™ Rapid Exchange FFR System – the world’s first Rapid Exchange FFR system. This device features new technology designed to provide physicians with a fast and easy way to perform Fractional Flow Reserve (FFR) procedures.

Healthcare products company Medline is showcasing many products at AORN this weekend, but is using the event to launch Surgiseal Twist, a new delivery device for a cyanoacrylate topical skin adhesive.

MRI technology specialist, ScanMed of Resonance Innovations LLC, will be introducing its new Orbit and Mandible Array and Targeting System at this year’s AAPOS (American Association for Pediatric Ophthalmology and Strabismus) Annual Meeting in Palm Springs from April 2-6, 2014.

BD has unveiled its BD Micro-Fine Ultra™ with 5-bevel needle technology, which it is launching in the UK and Ireland. The company claims clinically demonstrated improved injection comfort for diabetes patients.

Better known for being a big player in extremities trauma, orthopaedic company Acumed says it is venturing into the new and expanding market of orthopaedic implants and instrumentation for the surgical repair of fractures and joint disruptions of the pelvis.

Benvenue Medical has chosen the Society for Interventional Radiology Annual Scientific Meeting at which to announce the full commercial launch of its system, supported by further favourable clinical data.

St. Jude Medical, Inc. has announced the global launch of the Optisure™ Defibrillation Lead, joining the Optim™ lead family, which includes the company’s now famous Durata™ Defibrillation Lead.

St. Jude Medical, Inc. has seen its Prodigy™ Chronic Pain System with Burst Technology gain CE Mark approval, which it says will be followed by European launch.

Imaging device Specialist NinePoint Medical, Inc., has completed a $34 million Series B financing which it says will support the ongoing commercial launch of the NvisionVLE Imaging System in the U.S., as well as development of the company’s expanded product offering.